Hospira Inc. recalls Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 via…

Recall date

March 23, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1137-2016

FDA classification

Class I

Brand / firm

Hospira Inc.

Sold / distributed

Nationwide, United Arab Emirates, Kuwait, and Bahrain

Why it was recalled

Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.